Blog Archive
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2008
(297)
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May
(42)
- Delphi Medical Systems : New Delphi Portable Oxyge...
- ImClone : Significant Data on ERBITUX (cetuximab)...
- Olympus Medical Systems and Spiration : Agreement ...
- Pfizer : New Data in Lung Cancer to Be Presented a...
- Array BioPharma and AstraZeneca : New Phase 2 Dev...
- Guided Therapeutics, Inc. and Konica Minolta : to ...
- Arriva Pharmaceuticals Granted Fusion Protein Patent
- EPIX Pharmaceuticals : Phase 2a Data at American T...
- Osiris Therapeutics : Phase II Clinical Trial Eval...
- 3M : First FDA-Cleared Respirators for General Pub...
- VGX Pharmaceuticals : multi-year production agreem...
- Nektar : Patent Covering Pulmonary Targeted Antibi...
- Oscient & Menarini : Regulatory Filing for FACTIVE...
- GE HEALTHCARE & Merck : GLOBAL MOLECULAR DIAGNOSTI...
- Sepracor & Arrow : Global License and Development ...
- Critical Therapeutics : Definitive Agreement to Me...
- KaloBios : Patient Dosing in its U.S. Phase 1 Tria...
- Compugen : Discovery of Blood Based Biomarker for ...
- Nabi Biopharmaceuticals Prevails in Opposition Hea...
- Gilead : Letairis (ambrisentan) Phase IV Program
- Targacept : Designation of Lead Compound in Smokin...
- GenVec : Grant for RSV Vaccine Program
- Pipex Pharmaceuticals : FDA Orphan Drug Designatio...
- Pfizer Japan : Champix the First Prescription Ora...
- Masimo : new Rad-87 Pulse CO-Oximeter, Patient Saf...
- Discovery Labs : Approvable Letter from FDA for Su...
- PARI : eFlow delivers Alnylam RNAi Therapeutic in ...
- Monogram Biosciences : HER1 and HER3 VeraTag™ Assa...
- MedImmune : Phase 3 Data Regarding Anti-RSV Antibo...
- United Therapeutics : Treprostinil Data Presented...
- Oncothyreon's PX-12 and PX-866 Data presented at A...
- GlaxoSmithKline : further progress of oncology por...
- AstraZeneca : Marketing Application in Europe for ...
- Proteolix : Phase 2 Clinical Trial of Carfilzomib ...
- Poniard Pharmaceuticals : Final Picoplatin Data fr...
- Boehringer Ingelheim : Data suggests promising ove...
- Biomoda : Allowance allows company to expand paten...
- Roche acquires Piramed
- Biocon Limited : Phase IIb trials for NSCLC for B...
- Nonin Medical : World’s first Bluetooth-enabled, w...
- AstraZeneca : an sNDA for SYMBICORT for COPD indic...
- GlaxoSmithKline : Advair 250/50 for reduction of e...
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May
(42)
May 1, 2008
AstraZeneca : an sNDA for SYMBICORT for COPD indication
April 30, 2008 – AstraZeneca (NYSE: AZN) announced that it submitted a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration (FDA) for approval of a new indication for SYMBICORT® (budesonide/formoterol fumarate dihydrate) Inhalation Aerosol for the treatment of patients with Chronic Obstructive Pulmonary Disease (COPD). SYMBICORT is currently approved for the long-term maintenance treatment of asthma in patients 12 years and older... AstraZeneca's Press release -